Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain

Preventive Medicine Clinical Trial

Official title:

Preventing Chronicity of Sub-acute Low Back Pain by Altering the Neural Emotional Response to Pain - a Pilot Study Addressing the Efficacy and Feasibility of an Interoceptive Exposure Technique.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05450263
• Other study ID #: Research Institute Orton
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Orton Orthopaedic Hospital
• Contact: Tage Orenius
• Phone: +358505223780
• Email: tage.orenius[@]orton.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim of the study It could be stated that chronification of low back pain in some respects depends on the emotional reactions to the acute pain state. This approach enables advancing novel therapeutics for preventing pain chronification by altering the pain-related affective states. At present, no publication evaluating the efficacy of IET in altering brain responses related to sub-acute low back pain seems available. Neither have we found any studies specifically addressing the efficacy of mindfulness training on the functional connection between PFC and NAc. The aim of this study project is three-fold: 1. A systematic literature review of behavioural methods in the prevention of low back pain chronicity Orenius T, Silén E, Nuortimo A, Ristolainen L. Psychological interventions in preventing chronicity of sub-acute back pain: a systematic review. Scand J Pain. 2022 Jan 24;22(2):211-217. doi: 10.1515/sjpain-2021-0063. PROSPERO: CRD42019053580 2. A pilot study (n=7+7) to address the efficacy and feasibility of IET in preventing chronicity of sub-acute pain 3. A full scale study (n=20+20) addressing the efficacy and feasibility of IET in the prevention of chronicity of sub-acute low back pain

Description:

To assess the efficacy of IET on the chronification of LBP, participants who are found to have a higher risk of pain chronification due to the presence of a biomarker (positive mPFC-Nac connectivity) will be randomized to the intervention group (IET) or control group A (treatment as usual). To assess how well this biomarker predicts the chronification of LBP, participants who are not found to have the biomarker will be assigned to control group B (treatment as usual).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 14
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

The selection of subjects will meet same criteria as in the study by Baliki et al. (2010).

• Low back pain diagnosed by a clinician
• Low back pain intensity > 40/100 on NRS
• Low back pain duration 4-12 weeks

Exclusion Criteria:

• Other chronic painful condition
• Systemic disease
• History of head injury
• Diagnosed psychiatric disorders
• Depression exceeding mild depression (score > 19), as defined by Beck's Depression Inventory (BDI)

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Preventive Medicine

Intervention

Behavioral:
• Interoceptive exposure
A pilot study addressing the efficacy and feasibility of an interoceptive exposure technique.

Locations

Country	Name	City	State
Finland	Orton Orthopaedic Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Orton Orthopaedic Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity change	Measured by numeric rating scale (NRS) with a pain intensity ranging from "no pain" to "worst pain" (1 to 10) according to the conventional use of NRS	Pain intensity at the beginning of the intervention and pain intensity change at 3 months and 12 months
Secondary	Anxiety change	Anxiety symptoms are measured by State-Trait Anxiety Inventory (STAI)	Anxiety at the beginning of the intervention and anxiety change at 3 months and 12 months.
Secondary	Depression change	Depression is measured by Beck Depression Inventory (BDI), version II	Depression at the beginning of the intervention and depression change at 3 months and 12 months.